AMRI Receives FDA Nod for Docetaxel Drug Product Manufacturing

AMRI, a contract research and manufacturing organization, reports that docetaxel Injection (non-alcohol formula) has been approved for commercial manufacture at its Burlington, Massachusetts aseptic fill-and-finish facility following US Food and Drug Administration’s (FDA) pre-approval inspection for this drug product.

Eagle Pharmaceuticals, Inc., which entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. in October 2015 to market, sell, and distribute docetaxel injection in the United States, announced the FDA’s US approval of docetaxel injection in December 2015. Docetaxel injection is the first alcohol-free formulation approved in the United States for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

AMRI provides integrated development, formulation, and commercial parenteral solutions, which includes pre-formulation, formulation and process development; cGMP injectable formulation development and clinical drug product; and late-phase and commercial parenteral manufacturing. AMRI’s Burlington facility is equipped to provide formulation development, cGMP manufacturing and sterile filling of parenteral drugs, including both small-molecule drug products as well as biologics.

Source: AMRI

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